A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent disclosure, as it appears in the Patent and Trademark Office public patent files or records, but otherwise reserves all copyright rights whatsoever.
The invention disclosed herein relates to an apparatus for administering electromagnetic energy to tissue for medical and research purposes. In particular, the present invention relates to such apparatus which administers the electromagnetic energy athermapeutically (non-thermally). Also, the invention relates to a method for providing and updating patient and research files which store information regarding the treatment parameters and the patient or research project.
Prior art apparatus for administering high frequency electromagnetic energy athermapeutically has been available for many years from Diapulse Corporation of America, of Great Neck, N.Y. Such apparatus, referred to by Diapulse Corporation of America as the xe2x80x9cDiapulse Wound Treatment Systemxe2x80x9d(trademark) (xe2x80x9cDWTSxe2x80x9d(trademark) ), and referred to herein as xe2x80x9cDIAPULSE(copyright) apparatus,xe2x80x9d has been used extensively for the athermapeutic treatment of damaged tissue, and treatments using such apparatus have come to be identified as xe2x80x9cDIAPULSE(copyright) treatmentsxe2x80x9d or xe2x80x9cDIAPULSE(copyright) Therapyxe2x80x9d. The following patents relate to earlier DIAPULSE(copyright) apparatus, including the treatment head thereof: U.S. Pat. Nos. 2,276,994; 2,276,995; 2,276,996; 3,043,310; 3,181,535; 3,464,010; 3,670,737 and 4,226,246; Canadian Patent No. 679,371; and French Patent No. 2,301,965. The entire disclosures of all of those patents are hereby incorporated herein by reference.
DIAPULSE(copyright) apparatus available from Diapulse(copyright) Corporation of America generates and delivers short bursts of high peak power RF electromagnetic pulses to an area to be treated in or on the patient""s body without causing any significant rise in temperature in the treated area. A DIAPULSE(copyright) treatment applies the energy to the desired treatment area by radiating it from a treatment head placed adjacent the treatment area, either in direct contact with or in close proximity to the treatment area. The specific operating parameters of DIAPULSE(copyright) treatments are: radiation of RF electromagnetic pulses of 27.12 MHz (11 meter band) in short, squared bursts of 65 xcexcsec., at selectable burst repetition rates between 80 to 600 bursts per second (duty cycle between 0.5% and 3.9%), at selectable peak powers between about 300 and about 1000 watts, providing average powers of from about 1.5 W to about 38 W. Pulse frequencies of 0.5 of 27.12 Mhz and 1.5 of 27.12 Mhz may also be used, i.e. pulse frequencies of 13.56 MHz and 40.68 Mhz, respectively. The treatment head size and the treatment area size are such, that with the parameters given above, the DIAPULSE(copyright) treatment is athermapeutic, and the pulsed energy delivered to the treatment area is xe2x80x9cnon-thermalxe2x80x9d in a medical sense.
The efficacy of the high amplitude, short duration electromagnetic pulses applied in DIAPULSE(copyright) treatments resides in the ability of these pulses to affect the electrical state of living cells, rather than to generate heat. As understood, these high amplitude, short duration electromagnetic pulses achieve beneficial effects by accelerating the return of the electrical state of damaged tissue to its normal condition, thus hastening the resulting electrochemical and chemical responses, and increasing blood flow, which are involved in healing and pain relief. Scientific blind, double blind and control studies have proved that DIAPULSE(copyright) treatments accelerate the healing of tissue damaged by burn, laceration, contusion, abrasion and surgical intervention, reduce edema, erythema, and inflammation, and prevent and relieve acute and chronic pain. These studies also show DIAPULSE(copyright) treatments to be effective in the treatment of a wide range of specific applications from the treatment of head injuries, pressure ulcers and acute and chronic wounds (due to surgery and otherwise) to the treatment of ankle sprains. See, for example, Ross, Jesse, Utilization of Pulsed High Peak Power Electromagnetic Energy (Diapulse Therapy) to Accelerate Healing Processes, Digest International Symposium, IEEE Antennas and Propagation Society, Stanford University, Jun. 20-22, 1977, pp. 146-149; Ross, Jesse, Results, Theories, and Concepts Concerning the Beneficial Effects of Pulsed High Peak Power Electromagnetic Energy (Diapulse(copyright) Therapy) in Accelerating the Inflammatory Process and Wound healing, presented at The Bioelectromagnetics Society 3rd Annual Conference, Washington, D.C., Aug. 9-12, 1981; Ross, Jesse Evolution, Prevention and Relief of Acute and Chronic Pain with the Application of Diapulse(copyright) Therapy (Pulse of High Peak Power Electromagnetic Energy), published in Schemerz, 1/1984, pp. 9-16; Ross, Jesse, Biological Effects of pulsed Peak Power Electromagnetic Energy using Diapulse(copyright), published in Emerging Electromagnetic Medicine, O""Connor, M. E., Bentall, R. H. C., Monohan, J. C., editors, Springer-Verlag, 1990, pp. 269-281; Itoh, Masayoshi et al., Accelerating Wound Healing of pressure Ulcers by Pulsed High Peak Power Electromagnetic Energy (Diapulse(copyright)), Decubitus, 4(1):24:February 1991; Pennington, Gerard M., et al., Pulsed, Non-Thermal, High Frequency Electromagnetic Energy (Diapulse(copyright)) in the Treatment of Grade I and Grade II Ankle Sprains, Military Medicine, Vol. 158, No. 2, February 1993; Sambasivan, M., Pulsed Electromagnetic Field in Management of Head Injuries Neurology India, (1993) 41 (Suppl.), pp. 56-59; Salzberg, Andrew C. et al., The Effects of Non-Thermal Pulsed Electromagnetic Energy (Diapulse(copyright)) on Wound Healing of Pressure Ulcers in Spinal Cord-Injured Patients: A Randomized Double-Blind Study, Wounds, Vol. 7, No. 1, January/February 1995, pp. 11-16; Tung, Shirley et al., The Application of Diapulse(copyright) in the Treatment of Decubitus Ulcers: Case Reports, Contemporary Surgery, Vol. 47, No. 1, July 1995, pp. 27-32.
There is a need, however, for an improved apparatus capable of administering DIAPULSE(copyright) treatments, and also capable of applying electromagnetic energy to a treatment area for modified DIAPULSE(copyright) treatments and for new applications, both thermal and non-thermal, including research.
It is an object of the invention disclosed herein to provide an improved apparatus for the application of electromagnetic energy for medical treatments and/or research.
It is another object of the invention to provide such treatment apparatus with improved and/or expanded control of treatment parameters.
It is another object of the invention to more precisely control parameters of medical and/or research treatments in an apparatus which delivers high frequency electromagnetic pulses to treatment areas; other objects are to do so using a minimal number of components, and to be able to vary such treatment parameters in software, in response to settings input by a user or in response to settings stored in the apparatus. Another object is to vary the settings stored in the apparatus at the site of the apparatus and/or remotely.
It is another object of the invention to control more closely the power output of high frequency electromagnetic pulses radiated by apparatus for conducting medical treatments and/or research. Another object is to provide for xe2x80x9cfail-safexe2x80x9d operation in the sense that such apparatus does not radiate the electromagnetic pulses at unsafe power levels, or for time periods sustained for longer than the time periods of the bursts, or when the apparatus is not set to radiate the pulses.
It is another object of the invention to automatically store in apparatus for conducting medical treatments and/or research (or apparatus coupled thereto) treatment parameters and other information for each patient or research project and for each treatment session. Another object is to process and/or print these parameters and information either directly from or by the apparatus, or after transfer of the parameters and information to other apparatus or storage devices. Another object is to be able to transfer such information, including information which controls the treatment parameters for a particular patient or treatment session, into and out of such apparatus through a communication link from and/or to a remotely located apparatus. Another object is to provide multi-media capability for such apparatus which includes at least storing and/or displaying of images.
It is another object of the invention to provide some indication or alarm (e.g., audio, visual or both, and/or an electronic record), when the treatment head of a medical treatment apparatus is moved out of the position it was initially set in (or a patient moves relative to the treatment head).
It is another object of the invention to provide a transportable apparatus for conducting medical treatments and/or research in which treatment parameters may be changeably entered at a given site, and the treatment defined by the entered parameters carried out by the apparatus at another site.
It is another object of the invention to reduce power consumption and/or power dissipation in apparatus for generating and delivering bursts of high peak power electromagnetic RF pulses.
A more specific object is to improve the prior DIAPULSE(copyright) apparatus in one or more, and preferably all, of the following ways, while at the same time retaining the specific operating parameters described above of DIAPULSE(copyright) treatments:
more precise control of treatment parameters, including burst repetition rate, power level, and treatment duration, using a minimal number of hardware components;
dynamic adjustment of power radiated to a treatment area to a selected power level;
the capability of varying treatment parameters in software beyond the variations possible in the earlier DIAPULSE(copyright) apparatus;
the automatic creation and updating of a patient file which logs treatment parameters and other information, and the ability to access, upload and down load the patient file and information therein;
the reduction of power consumption and power dissipation by and in the improved apparatus; and
provide an entirely xe2x80x9csolid-statexe2x80x9d apparatus.
An improved apparatus for applying electromagnetic energy to a treatment area is disclosed herein which has the capability of maintaining (and does maintain) the specific operating parameters described above of DIAPULSE(copyright) treatments, has the capability of regulating these parameters more precisely and/or for safety purposes, and also the capability of changing these parameters for use in DIAPULSE(copyright) type treatments and research, and in new or modified treatments and research, both non-thermal and thermal. A method for creating and updating, etc., a patient or research file is also disclosed. The file may be multi-media, e.g., include images and/or sound.
When operated in a non-continuous or pulsed manner, as when administering DIAPULSE(copyright) treatments, the inventive apparatus generates and radiates bursts of RF electromagnetic energy to a treatment area, with reduced power consumption and dissipation by causing the primary (or major) RF power handling or generating component(s) to be in an off or non-conductive state except substantially during the bursts. According to the invention, power to the primary RF power component(s) is continuously maintained, i.e., the power to the primary RF power component(s) is not pulsed, and the primary RF power component(s) is (are) caused to turn on or conduct substantially only during the bursts. Specifically, the inventive apparatus includes a primary RF power component in the form of one or more RF power amplifiers which output high peak RF power pulses in bursts. According to the invention, power is connected to the RF power amplifier(s) continuously, and the RF power amplifier(s) is (are) biased on for the length of each burst and is (are) biased off substantially at all other times. In the preferred embodiment, two RF power amplifiers are provided connected in parallel, and a power splitter is provided to supply input pulses to the two RF power amplifiers from a common source, e.g., an RF preamplifier, and a power combiner is provided at the outputs of the two RF power amplifiers to combine the pulses output by the RF power amplifiers and provide the combined pulses to a radiating device, e.g., a treatment head.
In another embodiment, the primary RF power component(s) may be one or more solid state RF power oscillators which are selectively biased into oscillation during the bursts.
In the preferred embodiment, bias is supplied to the RF power amplifier(s) by a bias circuit which may be enabled and disabled by a control signal. In accordance with the invention, the bias circuit is enabled for substantially only the duration of each burst, i.e., are gated into enablement for substantially only the duration of each burst. The bias circuit in the preferred embodiment comprises at least one controllable voltage regulator coupled to supply, when enabled, the bias voltage to the RF power amplifiers(s).
In the preferred embodiment, power is supplied to the primary RF power component(s) through a power storage device which stores power between bursts supplied by a power supply, and then releases the stored power to the primary RF power component(s) during the bursts. Thus, the power supply continuously supplies power to the power storage device at a low rate compared to the peak power of the RF pulses. This has the advantage that the power supply may have a continuous power rating which is substantially less than the peak power of the pulses in each burst or series of bursts output by the primary RF power component(s). Also, in the preferred embodiment, pulses to be amplified are not supplied to the primary RF power component(s) except during the time periods of the bursts. In the preferred embodiment, the power supply is a DC power supply and the power storage device(s) comprise one or more capacitors.
The inventive apparatus controls the repetition rate of the bursts of pulses in accordance with a burst repetition rate selected by a user, and includes a configurable logic device, coupled to a pulse generator, which comprises a plurality of separately configurable logic elements. The configurable logic device outputs pulses to be amplified during the bursts and outputs signals which control operating parameters, e.g., the burst repetition rate and burst duration. In the preferred embodiment, these signals control the voltage regulator(s) which supplies(y) the bias voltage(s) to the power amplifier(s). The configurable logic device may be configured to support operation of the apparatus for all of these operating parameters without being reconfigured, but can be reconfigured, if desired, to change an operating parameter or parameters. Alternatively, the configurable logic device may be configured to operate in a plurality of modes in which the configurable logic device is reconfigured, preferably dynamically, from mode to mode. In the preferred embodiment, the reconfigurable logic device is dynamically reconfigurable to operate in each of a plurality of modes. In the preferred embodiment, a memory device is provided to store a plurality of configuration files, each file when loaded into the configurable logic device causing the configurable logic elements to be configured to operate in one of the plurality of modes. A controller or processor is coupled to the configurable logic device and the memory device to select the configuration file stored in the memory device to be loaded into the configurable logic device based on a desired burst duration and/or repetition rate which may be input by a user or determined by the apparatus according to a program or dynamically in response to measured or detected parameters. In the preferred embodiment, the burst repetition rate is selected by the user and the burst duration is fixed, but could be made variable, and the configurable logic device is a logic cell array.
According to the invention, the controller comprises a system processor or controller and a local processor or controller. The configurable logic device is coupled to the local controller which causes information stored in a memory device coupled to the local controller to be transferred to the configurable logic device to configure or program it. The local controller is directed by the system processor which is preferably that of a computer. In the preferred embodiment, the inventive apparatus includes at least one input device coupled to the system processor for inputting information related to one or more of the parameters of the bursts, including but not limited to the following: the time between bursts (burst repetition rate), the duration of the bursts, a desired peak power level of the pulses in the bursts, and an overall length of time that the bursts are to be supplied. In the preferred embodiment, the burst length is in the order of 65 xcexcsec., and the burst repetition rate is from about 80 bursts per second to about 600 bursts per second (xe2x80x9cbpsxe2x80x9d) (time between bursts of from about 12.5 msec. to about 1.6 msec).
The parameters may be set by a user through any suitable input device (e.g., keyboard, mouse and display, touch screen, digitizer). In lieu of or in addition to setting parameters with an input device, the parameters may be stored in memory and set into the apparatus according to a program controlling the processor. The parameters may be input into or changed in the memory by any suitable input device, or by downloading from an apparatus co-located with or located remotely from the inventive apparatus, or dynamically in response to measured, detected or monitored conditions or parameters.
Like earlier DIAPULSE(copyright) apparatus, the preferred embodiment of the inventive apparatus generates high peak power RF pulses in short bursts for athermapeutic treatment. This apparatus includes an RF pulse generator, an amplifier, and a radiating device coupled to the amplifier for radiating electromagnetic pulses received from the amplifier.
According to preferred embodiments of the invention, the inventive apparatus includes a closed loop, real time power adjustment system for automatically adjusting RF electromagnetic power delivered to a load to a desired level. The power adjustment system comprises a power monitor which provides in real time a first (or forward) power level signal related to the forward power level of RF pulses radiated by the radiating device. This signal may be used by itself to regulate the peak power level of the pulses output by the power amplifier(s) to the load, which here comprises the treatment head and the treatment area. The amplifier includes a variable gain stage. A processor or controller which controls the timing of the bursts is coupled to receive at least the first signal, calculate therefrom the forward power level of the RF pulses delivered to the load, and provide a control signal to the amplifier gain control stage which causes the amplifier to adjust the amplitude of RF pulses supplied to the radiating device at or closer to the desired power level in real time, e.g., within the time period between bursts. The apparatus thus can sample and regulate the peak power output by the apparatus, and does not depend upon colormetric measurements to regulate the power output. This real-time power measurement and regulation capability minimizes the time period during which power may be radiated at an unwanted, and perhaps unsafe, level.
In the preferred embodiment, the power monitor also provides a second (or reflected) power level signal related to the reflected power level of an RF signal reflected by the load. The processor or controller also receives the second signal, calculates the power reflected from the load and provides the control signal to the variable gain stage in response to both the first signal and the second signal.
In the preferred embodiment, the power monitor provides analog first and second power level signals, and the apparatus comprises an analog to digital converter coupled to receive the analog power level signals from the power monitor and provide digital power level signals to the processor, and the processor provides digital signals to the variable gain stage which cause the amplifier to supply RF pulses at the desired power level. In the preferred embodiment, the processor provides the digital signals to a digitally controlled resistance, which controls the gain of the variable gain stage.
The power adjustment system may also include a second closed loop for automatically limiting the RF electromagnetic power delivered to the load to a below a maximum level. In the preferred embodiment, the second loop is analog, is not controlled by a processor and is responsive only to the first analog power level signal. This second closed loop includes a circuit which receives the first analog power level signal and prevents the power level of the amplified pulses from exceeding a given maximum value. Also, the system may include a third loop which ensures that the electromagnetic power is not radiated unless the control signal(s) directing same are present. The second and third loops provide the xe2x80x9cfail-safexe2x80x9d operation referred to above.
In the preferred embodiment, the variable gain amplifier stage comprises one or more solid state devices (e.g., transistors) whose DC supply or bias level is adjusted to adjust the gain thereof. The adjustment may be made by the power monitor system as described above, or in response to data or settings input by a user or stored in the apparatus in software or hardware. An RF transformer is coupled to the output of the solid state device(s) to couple pulses output thereby to a preamplifier or amplifier. The DC supply or bias is supplied to the primary of the RF transformer which supplies the DC to the solid state device(s). In the preferred embodiment, the solid state device is an RF transistor having its collector coupled to the transformer primary and operating in the common base mode. The digitally controlled resistance is coupled to another transistor operating in the common emitter mode with its emitter coupled to the transformer primary, its collector coupled to a source of DC power, and its base coupled to the variable resistance. This arrangement enables the gain of the RF transistor to be controlled with low frequency components.
The power adjustment system is used in the preferred embodiments of the invention for the application of DIAPULSE(copyright) treatments, but the entire power adjustment system or parts thereof may be used in other applications, both thermal and non-thermal.
The invention also provides an indication or alarm when there has been a change by a given amount of the RF energy delivered to the treatment area (detected in the preferred embodiment by a ratio of the forward and reflected power levels at the treatment head). This may be caused by relative movement between the treatment head and the treatment area, i.e., in the case of a patient, either the treatment head or the patient has moved, or other factors. Such movement is manifested by a mismatch in the forward and reflected power levels at the treatment head, which is detected. When the mismatch reaches or passes a given value, an indication is provided by the apparatus, which could be audio, visual or simply an electronic recording of same. The indication may be provided by any conventional audio device, display, indicator, etc.
According to the invention, files such as patient or research project files may be automatically generated, updated and maintained in apparatus for applying treatments to a treatment area. Such apparatus may be apparatus of the type disclosed or referred to herein, or other apparatus. The apparatus receives information input by the user, which includes identifying information about the patient or project, and at least one treatment parameter selected by the user. The apparatus measures, monitors, detects, or tracks the at least one treatment parameter while the apparatus is administering the treatment, creates or modifies at least one file based on the identifying information about the patient or project, and stores the identifying information and the at least one treatment parameter in the at least one file. The apparatus may also measure or obtain treatment information and/or at least one treatment attribute, and also store the treatment information or attribute in the file. For example, the treatment information or attribute may be optical data (e.g., scanned photographically, magnetically, electromagnetically, ultra-sonically, etc.) relating to the treatment area, which provides the apparatus with multi-media capability. If desired, sound may also be provided to enhance the apparatus"" multi-media capability. The at least one treatment attribute may be obtained while the apparatus is administering the treatment, or before or after the treatment has been administered. The information in the file may be displayed, printed and/or stored, and may be accessed for uploading, down loading and modification by other apparatus, either by direct connection or a communication link.